Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientif...( Study Showed Larazotide Acetate Pre...),Health

Study Showed Larazotide Acetate Prevented Immunologic Changes Induced by

Gluten in Patients with Celiac Disease Additional Data Indicates Potential in Treating Inflammatory Bowel Disease

ORLANDO, Fla., Oct. 7 /PRNewswire/ -- Alba Therapeutics Corporation presented results from two clinical studies this week at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting. Data from study CLIN 1001-004, the first Phase IIa trial conducted in celiac disease and the first to assess the prevention of immunologic changes in celiac disease, showed that larazotide acetate (AT-1001) successfully demonstrated prevention of gluten-induced immunologic changes in celiac patients.

Results from the study showed that larazotide acetate is the first pharmacologic agent to prevent changes in blood mononuclear cell populations (specifically T-reg cells and B Cells) and other markers of immunological change associated with active celiac disease. This data suggests that larazotide acetate offers potential as a future treatment of celiac disease. Results from a second poster presented at ACG showed that larazotide acetate also inhibited the effect of inflammatory cytokines, including tumor necrosis factor (TNF-alpha) and interleukin (IL-4) on intestinal epithelial permeability, in vitro, further suggesting that the product offers potential as a future treatment for inflammatory bowel disease (IBD).

Larazotide Acetate is a novel, non-absorbed peptide currently being studied in Phase IIb trials for the treatment of celiac disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted "Fast Track" designation from the U.S. Food and Drug Administration (FDA) for this indication.

Celiac disease affects approximately one percent of individuals in the United States and Europe, or approximately 6.5 million individuals. The only accepted management for the dise
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